Standard Operating Procedure
Tamoxifen
This is an SOP template and is not complete until: 1) lab specific information is entered into the box below 2) lab specific protocol/procedure is added to the protocol/procedure section and
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Laboratory Safety Manual and Chemical Hygiene Plan.
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Type of SOP: ☐ Process ☒Hazardous Chemical ☐ Hazardous Class
Purpose
Tamoxifen is an antagonist of estrogen receptor and is thus used in the treatment of ER positive breast cancer. Tamoxifen is metabolized in the liver into its active form that binds to ER and causes cell arrest. Due to its various effects, tamoxifen is the subject of much research. Tamoxifen is water insoluble and should be dissolved in methanol, ethanol, propanol, propylene glycol, DMSO, or chloroform.
Physical & Chemical Properties/Definition of Chemical Group
CAS#: 10540-29-1
Class: Carcinogen / Reproductive Toxin
Molecular Formula: C26H29NO
Form (physical state): Solid / solid crystalline powder
Potential Hazards/Toxicity
Tamoxifen has been classified as carcinogenic to humans by IARC and NTP.
LD50 Oral: 4100 mg/kg [Rat]
Although little data is available, tamoxifen may be harmful if inhaled, swallowed, or absorbed through the skin. It can cause irritation of the skin, eye, and respiratory tract.
Toxic Effects: Tamoxifen is a toxic substance.
Acute Effects: Hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
Chronic Effects: CARCINOGENIC EFFECTS: Not available. MUTAGENIC EFFECTS: Not available. TERATOGENIC EFFECTS: Not available DEVELOPMENTAL TOXICITY: Classified Reproductive system/toxin/female, Development toxin [POSSIBLE]. Repeated or prolonged exposure is not known to aggravate medical conditions.
Personal Protective Equipment (PPE)
Respirator Protection
Respirators should be used only under any of the following circumstances:
· As a last line of defense (i.e., after engineering and administrative controls have been exhausted).
· When Permissible Exposure Limit (PEL) has exceeded or when there is a possibility that PEL will be exceeded.
· Regulations require the use of a respirator.
· An employer requires the use of a respirator.
· There is potential for harmful exposure due to an atmospheric contaminant (in the absence of PEL)
· As PPE in the event of a chemical spill clean-up process
Lab personnel intending to use/wear a respirator mask must be trained and fit-tested by EH&S. This is a regulatory requirement. (https://www.ehs.ucla.edu/ep/ih/resp)
Hand Protection
Double nitrile gloves.
NOTE: Consult with your preferred glove manufacturer to ensure that the gloves you plan on using are compatible with tamoxifen.
Refer to glove selection chart from the links below:
http://www.ansellpro.com/download/Ansell_8thEditionChemicalResistanceGuide.pdf
OR
http://www.showabestglove.com/site/default.aspx
OR
http://www.mapaglove.com/
Eye Protection
Tightly fitting safety goggles. Face shield (8-inch minimum) is often recommended.
Skin and Body Protection
Lab coats should be worn. These laboratory coats must be appropriately sized for the individual and be buttoned to their full length. Laboratory coat sleeves must be of a sufficient length to prevent skin exposure while wearing gloves. Full length pants and close-toed shoes must be worn at all times by all individuals that are occupying the laboratory area. The area of skin between the shoe and ankle should not be exposed.
Hygiene Measures
Always wash hands after removing gloves following handling of tamoxifen.
Engineering Controls
Always handle tamoxifen inside a certified chemical fume hood or a ducted biosafety cabinet.
First Aid Procedures
If inhaled
Move person into fresh air. If not breathing, give artificial respiration. Consult a physician.
In case of skin contact
Take off contaminated clothing immediately. Wash off with soap and plenty of water for 15 minutes. Take victim immediately to hospital. Consult a physician.
In case of eye contact
Rinse thoroughly with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical aid immediately.
If swallowed
Do not induce vomiting. Never give anything by mouth to an unconscious person. Rinse mouth with water. Consult a physician.
Special Handling and Storage Requirements
The chemical solid or solutions will be made in chemical fume hoods and will be stored in clearly marked containers. Tamoxifen liquid solutions (10 mg/ml dissolved in corn oil) will be stored at room temperature in clearly marked secondary containers. Liquid waste will be collected for disposal by EH&S.
All chemicals containing tamoxifen must be secondarily contained with proper signage.
Signage is required for the container, designated work area and storage location. Sign wording must state the following: “DANGER, CANCER HAZARD, CARCINOGEN”
Spill and Accident Procedure
Chemical Spill Dial 911 and x59797
Spill – Assess the extent of danger. Help contaminated or injured persons. Evacuate the spill area. Avoid breathing vapors. If possible, confine the spill to a small area using a spill kit or absorbent material. Keep others from entering contaminated area (e.g., use caution tape, barriers, etc.).
Small (<1 L) – If you have training, you may assist in the clean-up effort. Use appropriate personal protective equipment and clean-up material for chemical spilled. Double bag spill waste in clear plastic bags, label and take to the next chemical waste pick-up.
Large (>1 L) – Dial 911 (or 310-825-1491 from cell phone) and EH&S at x59797 for assistance.
Chemical Spill on Body or Clothes – Remove clothing and rinse body thoroughly in emergency shower for at least 15 minutes. Seek medical attention. Notify supervisor and EH&S at x59797 immediately.
Chemical Splash Into Eyes – Immediately rinse eyeball and inner surface of eyelid with water from the emergency eyewash station for 15 minutes by forcibly holding the eye open. Seek medical attention. Notify supervisor and EH&S at x59797 immediately.
Medical Emergency Dial 911 or x52111
Life Threatening Emergency, After Hours, Weekends And Holidays – Dial 911 (or 310-825-1491 from cell phone) or contact the Ronald Reagan UCLA Medical Center (emergency room) directly at x52111 (located at 757 Westwood Plaza, enter from Gayley Avenue). Note: All serious injuries must be reported to EH&S at x59797 within 8 hours.
Non-Life Threatening Emergency – Go to the Occupational Health Facility (OHF), x56771, CHS room 67-120 (This is on the 6th floor, 7th corridor, room 120. Enter through the School of Dentistry on Tiverton Drive and proceed to the “O” elevator to the 6th floor.)Hours: M - F, 7:30 a.m. to 4:30 p.m. At all other times report to Ronald Reagan UCLA Medical Center (emergency room) at x52111. Note: All serious injuries must be reported to EH&S at x59797 within 8 hours.
Needle stick/puncture exposure (as applicable to chemical handling procedure) – Wash the affected area with antiseptic soap and warm water for 15 minutes. For mucous membrane exposure, flush the affected area for 15 minutes using an eyewash station. Page the needle stick nurse by dialing 231 from a campus phone, enter 93333 when prompted and then enter your extension. Hours: M – F, 8:00 a.m. to 4:00 p.m. At all other times report to Ronald Reagan UCLA Medical Center (emergency room) at x52111. Note: All needle stick/puncture exposures must be reported to EH&S at x59797 within 8 hours.
Decontamination/Waste Disposal Procedure
Wearing proper PPE, please decontaminate equipment and bench tops using soap and water. Please dispose of the spent sulfuric acid and disposables contaminated with sulfuric acid as hazardous waste
General hazardous waste disposal guidelines:
Label Waste
· Affix an on-line hazardous waste tag on all waste containers using the WASTe Online Tag Program https://ehs.ucop.edu/waste as soon as the first drop of waste is added to the container
Store Waste
· Store hazardous waste in closed containers, in secondary containment and in a designated location
· Double-bag dry waste using transparent bags https://www.ehs.ucla.edu/hazwaste/management/containers
· Waste must be under the control of the person generating & disposing of it
Dispose of Waste
· Dispose of regularly generated chemical waste within 90 days
· Call EH&S at x61887 for questions
· Empty Containers
o Dispose as hazardous waste if it once held extremely hazardous waste (irrespective of the container size) https://www.ehs.ucla.edu/hazwaste/types/extremely-hazardous
o Consult waste pick-up schedule
https://www.ehs.ucla.edu/hazwaste/management/pick-ups
Prepare for transport to pick-up location
§ Check on-line waste tag
§ Write date of pick-up on the waste tag
§ Use secondary containment
Safety Data Sheet (SDS) Location
Online SDS can be accessed at http://msds.ehs.ucla.edu.
Protocol/Procedure
Quantities covered by this SOP:
0-1 g from a 5 g reagent bottle
Conditions covered by this SOP:
4 °C – 37 °C
*Can be harmful if swallowed. May cause cancer, damage fertility or unborn child, or harm breastfed children. Handle with standard PPE.
Treating MCF7 cells with tamoxifen and measuring resulting cell growth and/or apoptosis
1. Prepare tamoxifen solution fresh in DMSO at 1g/mL and filter sterilize
2. Incubate MCF7 cells at different concentrations of tamoxifen (0/40/80/120/160 uM) for 0/2/6/24h time points in complete media
3. Following incubation, cell death may be assayed using an in vitro cytotoxicity assay
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Quantities covered by this SOP:
0-1 g from a 5 g reagent bottle
Conditions covered by this SOP:
4 °C – 37 °C
Influence of tamoxifen on aggregation of amyloidogenic proteins and peptides
The stock solution is about 10mM tamoxifen citrate in methanol (maximum 28 mg in 50ml methanol). Typically 5 ul of the tamoxifen citrate stock solution is added to the well of a 96-well plate, along with the peptide/protein under test and thioflavin T. As the peptide/protein aggregates, the plate reader measures increase of fluorescence from bound thioflavin T. Rates of fluorescence increase with and without tamoxifen citrate were compared.
NOTE
Any deviation from this SOP requires approval from PI.
Documentation of Training (signature of all users is required)
· Prior to conducting any work with tamoxifen., designated personnel must provide training to his/her laboratory personnel specific to the hazards involved in working with this substance, work area decontamination, and emergency procedures.
· The Principal Investigator must provide his/her laboratory personnel with a copy of this SOP and a copy of the SDS provided by the manufacturer.
· The Principal Investigator must ensure that his/her laboratory personnel have attended appropriate laboratory safety training or refresher training within the last one year.
Principal Investigator SOP Approval
Print name ______Signature______
Approval Date:
I have read and understand the content of this SOP:
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Tamoxifen 5 Date: 06/28/2016
UCLA- EH&S TV/PY